CHMP recommends approval of Avastin for NSCLC

Swiss drug major Roche says that Avastin (bevacizumab), its anticancer agent, is the subject of a positive approval recommendation from the European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP) for non-small cell lung cancer, an indication for which it gained US Food and Drug Administration clearance late last year (Marketletter October 23, 2006). Roche, which co-markets the drug with its majority-owned US biotechnology firm Genentech, said that the CHMP's guidance was based on data from the E4599 and AVAiL studies which indicated that the drug was effective in combination with a broad range of chemotherapies.

The E4599 trial, a Phase III examination of Avastin in 878 patients with locally advanced or metastatic recurrent NSCLC, showed that subjects treated with a 15mg/kg dose of the agent plus chemotherapy every three weeks achieved median survival of 12.3 months, versus 10.3 months seen in those treated with only chemotherapy. In addition, study participants given the drug in combination with paclitaxel and carboplatin had an approximate 27% improvement in overall survival, compared with those given chemotherapy alone.

The AVAiL program evaluated over 1,000 patients given one of two doses of Avastin (7.5mg/kg or 15mg/kg) plus cisplatin/gemcitabine or cisplatin/gemcitabine alone. The results showed that the drug prolonged progression-free survival between 20% to 30% versus chemotherapy plus placebo.